Results 121 to 130 of about 931,067 (298)

Opportunities for Improving the Drug Development Process: Results from a Survey of Industry and the FDA [PDF]

In the United States, the Food and Drug Administration (FDA) agency is responsible for regulating the safety and efficacy of biopharmaceutical drug products. Furthermore, the FDA is tasked with speeding new medical innovations to market.
Adrian H. B. Gottschalk, Ernst R. Berndt, Matthew W. Strobeck   +2 more
core  

Characterization of an Injectable Poly(vinyl alcohol)‐gelatin Hydrogel for Growth Factor Delivery in an Orthopedic Application

Advanced Healthcare Materials, EarlyView.
This work introduces photo‐crosslinkable tyraminated poly(vinyl alcohol)‐gelatin (PVA‐GT) hydrogels as tunable injectable platforms for tissue engineering and growth factor delivery applications. This schematic illustrates the two developed hydrogel formulations and the experimental workflow used to evaluate their physico‐chemical properties in vitro ...
Alessia Longoni, Gretel S. Major, Sam Arnold, Samuel Tomkins, Eugenia Spessot, Scott Loeffler, Kieran Lau, Richard Tan, Jessica Harte, Roslyn Kemp, Tess Reynolds, Jelena Rnjak‐Kovacina, Gary J. Hooper, Tim B. F. Woodfield, David C. Kieser, Khoon S. Lim   +15 more
wiley   +1 more source

Regulatory Science Needs for Neonates: A Call for Neonatal Community Collaboration and Innovation

Frontiers in Pediatrics, 2014
Susan K McCune, Yeruk Ager Mulugeta
doaj   +1 more source

Functional Regression [PDF]

, 2014
Functional data analysis (FDA) involves the analysis of data whose ideal units of observation are functions defined on some continuous domain, and the observed data consist of a sample of functions taken from some population, sampled on a discrete grid ...
Morris, Jeffrey S.
core  

Small Extracellular Vesicles from Neural Cells: Physiological and Pathological Roles, and Potential in Neurodegenerative Therapy

Advanced Healthcare Materials, EarlyView.
Neural cell–derived small extracellular vesicles (sEVs) are emerging as pivotal mediators in neurodegenerative diseases, exerting both pathogenic and therapeutic functions. This review synthesizes current evidence on how sEVs from distinct neural cell types regulate neurodegeneration, neuroprotection, biomarker discovery, and targeted drug delivery ...
Muhammad Waqas Salim, Wei Zhang, Lyndsey Collins‐Praino, Yuling Wang, Andrew Care   +4 more
wiley   +1 more source

Monoclonal antibodies targeting sites in respiratory syncytial virus attachment G protein provide protection against RSV-A and RSV-B in mice

Nature Communications
Currently, only Palivizumab and Nirsevimab that target the respiratory syncytical virus (RSV) fusion protein are licensed for pre-treatment of infants. Glycoprotein-targeting antibodies may also provide protection against RSV.
Youri Lee, Laura Klenow, Elizabeth M. Coyle, Gabrielle Grubbs, Hana Golding, Surender Khurana   +5 more
doaj   +1 more source

Maternal milk-derived lipids dictate neonatal macrophage phenotype and function

iScience
Summary: Unique properties of neonatal macrophages play an important role in tissue regeneration and susceptibility to infections. We discovered that exposure to neonatal mouse serum is sufficient to convert adult mouse macrophages into the neonatal ...
Lunhua Liu, Jiyeon Yang, Jiro Sakai, Ranadhir Dey, Isabelle Coppens, Hira L. Nakhasi, Mustafa Akkoyunlu   +6 more
doaj   +1 more source

FDA Centennial [PDF]

Science, 2006
openaire   +2 more sources

Design and Synthesis of Peptide‐Polyester Conjugates for Cell‐Mediated Scaffold Degradation

Advanced Healthcare Materials, EarlyView.
This work describes polycaprolactone (PCL)‐based biomaterials engineered to degrade in response to cell‐secreted proteases. A fast‐degrading peptide (Fast) sequence is integrated into a PCL conjugate backbone to produce a biomaterial that is selectively degraded by multiple cell types compared to its scrambled control (ScrFast).
Korina Vida G. Sinad, Natasha K. Hunt, Srujan Singh, Kelly B. Seims, Yingjie Wu, E. Thomas Pashuck, Warren L. Grayson, Lesley W. Chow   +7 more
wiley   +1 more source

Regulating Access to Developmental Drugs for Terminally Ill Patients: Abigail Alliance v FDA [PDF]

This amicus brief was filed in support of the Abigail Alliance for Better Access to Developmental Drugs in their lawsuit to force the Food and Drug Administration to provide patient access to drugs for cancer and other life-threatening illnesses after ...
Calfee, John E., Klein, Daniel B., Peltzman, Sam, Tabarrok, Alex, Zycher, Benjamin   +4 more
core   +1 more source